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Australia: Critical Challenge for Medical Devices Due to 3G Network Shutdown
Starting on 28 October 2024 , both Telstra and Optus will be shutting down their third-generation (3G) networks. This follows the earlier...

ARQon
Oct 22, 20241 min read


Singapore: Cybersecurity Labelling Scheme Presents a New Standard for Medical Devices
On 16 October 2024, the Cybersecurity Labelling Scheme for Medical Devices (CLS [MD]) was officially launched, following a successful...

ARQon
Oct 17, 20241 min read


Thailand: Wound Dressings Under Medical Device Perspectives
The Thailand Food and Drug Administration (TFDA) has released an infographic outlining the classification of wound dressings as medical...

ARQon
Oct 14, 20241 min read


Hong Kong: Revised Guidelines for Processing Application Renewal of Listed Medical Device (w.e.f 1 January 2025)
On 30 September 2024, the Medical Device Division (MDD) of Hong Kong introduced an updated procedure for processing renewal applications...

ARQon
Oct 8, 20241 min read


Indonesia: Mandatory GDP Certification for Medical Devices in the e-Katalog (w.e.f 1 January 2025)
The Ministry of Health of the Republic of Indonesia released a circular no. HK.02.02/E/1753/2024 to address the implementation of the...

ARQon
Sep 23, 20241 min read


EU: Compliance for Portable Batteries and Waste Batteries in Medical Devices and IVDs (w.e.f 18 August 2024)
Under the European Union (EU) Battery Regulation 2023/1542, released last year, all medical device and in-vitro diagnostic device (IVD)...

ARQon
Aug 27, 20242 min read


Australia: Prescription Lenses and Their Exemption from Medical Device Classification (15 June 2024)
Compliance effective on 15 June 2024 , prescription lenses for refractive correction are exempted from the requirement for inclusion in...

ARQon
Aug 21, 20241 min read


Vietnam: DMEC Publishes Decision No.2302/QD-BYT - Guidelines for Evaluation of Legal Documents in Class C and D Medical Device Registration Dossiers
As published by the DMEC of MoH Vietnam on 5 August 2024, Decision No. 2302/QD-BYT will replace Decision No.3007/QD-BYT regarding...

ARQon
Aug 20, 20241 min read


Hong Kong: Enhanced Measures Announced by DH for Medical Device Procurement Strategy
On the 4th of July 2024, the Department of Health (DH) announced its movement towards the second phase in enhancing the measures of...

ARQon
Jul 24, 20242 min read


Australia: Navigating New Regulation Changes for Medical Devices
The Therapeutic Goods Administration (TGA) revised the medical device regulations and introduced the amendments on the 26th of June 2024....

ARQon
Jul 17, 20243 min read


China: NMPA Outlines New Standards for Radiofrequency Therapy Devices (w.e.f 1 April 2026)
On the 2nd of July 2024, the Centre for Medical Device Evaluation (CMDE) announced the clarification by the National Medical Products...

ARQon
Jul 16, 20241 min read


Singapore: "NextGen MD Initiative" for Next Generation Medical Device Registrations (w.e.f 1 July 2024)
“NextGen MD Initiative” was introduced by the Health Sciences Authority (HSA) on 13 June 2024 to facilitate the registration of...

ARQon
Jul 9, 20241 min read


Thailand: Thai FDA Streamlines Medical Devices Registration Pathway (w.e.f 6 June 2024)
Effective 6 June 2024, the Thailand Food and Drug Administration (TFDA) has executed the new announcement on the registration...

ARQon
Jul 2, 20241 min read


India: New Self-Declaration Requirement Implemented for Pharmaceuticals & Medical Device Associations (d.d 30 June 2024)
On the 28th and 30th of May 2024, the Department of Pharmaceuticals of India released 2 Standing Orders regarding the new...

ARQon
Jun 25, 20241 min read


Malaysia: MDA Revokes Compliance Assessment Process Exemption for COVID-19 Test Kit Registration
The Medical Device Authority (MDA) released an announcement on 31 May 2024 about the revocation of the MDA Circular Letter...

ARQon
Jun 18, 20241 min read


France: ANSM Designates AFNOR as the Newest Notified Body
Medical devices to be marketed in the European market must obtain CE Marking as proof the devices meet the highest safety, health, and...

ARQon
Jun 12, 20241 min read


Malaysia: MDA Implements One License Per Establishment Role Policy (w.e.f 1 July 2024)
Based on the General Directive of the Minister of Health No.1/2024 , announced on 15 April 2024, following the provisions of the Medical...

ARQon
Jun 11, 20242 min read


India: CDSCO Grants Extension for Import Licenses of Class C and D Medical Devices
The Central Drugs Standard Control Organization (CDSCO) released a circular on 16 May announcing an extension for the importation of the...

ARQon
Jun 4, 20241 min read


Indonesia: Implementation of GDPMD Certification (CDAKB) as Marketing Authorization Requirement
The Indonesia Ministry of Health published an announcement on 11 May 2024, under Announcement No: FR.03.01/E/884/2024 about the...

ARQon
May 29, 20241 min read


Malaysia: Navigating Trade Barriers for Medical Devices in Nations without Diplomatic Ties
Medical devices for importation, exportation, or being placed in the Malaysian market are obligated to register with the Medical Device...

ARQon
May 14, 20241 min read
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